Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000015943
Ethics application status
Approved
Date submitted
27/08/2019
Date registered
14/01/2020
Date last updated
14/01/2020
Date data sharing statement initially provided
14/01/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study of clinical parameters and urinary biomarkers associated with pelvic ischemia in the human.
Scientific title
Comparison of lower urinary tract function and urinary biomarkers in patients with occlusion of the common iliac artery, before and after revascularization and normal population: a case control study.
Secondary ID [1] 298858 0
Nil known
Universal Trial Number (UTN)
U1111-1237-6576
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
lower urinary tract symptoms 313817 0
occlusion of the common iliac artery 313818 0
Condition category
Condition code
Renal and Urogenital 312223 312223 0 0
Other renal and urogenital disorders
Cardiovascular 312224 312224 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Our research programme attempts to elucidate the obscure field of pelvic ischemia by investigating clinical and urinary markers in patients with common iliac artery obstruction. All the patients are surgical candidates for iliac artery revascularization and are separated in 2 groups,
Arm 1-those suffering from Lower urinary tract symptoms and
Arm 2-those solely with obstruction.
Revascularization will be performed in patients already scheduled for restoration of vascular obstruction according to vascular surgeons' indications.
A control group of healthy individuals is also considered.
All participants are examined clinically with the use of validated questionnaires, non-interventional uroflow and ultrasound. Blood tests and examination for molecular biomarkers of ischemia in free-flow urine are performed. Additionally, arm 1- undergoes urodynamic evaluation (UDS)-interventional- at baseline. UDS is performed by placement of a small catheter in the urinary bladder through the urethra and another catheter in the rectum. The urinary bladder if filled with saline and following that the patient is ask to urinate. Bladder pressures are recorded during the whole process. During bladder filling the patient is asked about the urge to void and the urination pattern is also recorded. A patient info sheet will be distributed to all participants and an informed consent will be acquired.The urodymanic studies will be performed by expert personnel of Neuro-urological laboratory of the 2nd Urological Department of Aristotle University of Thessaloniki.The study will take place in the General Hospital of Thessaloniki, Papageorgiou.
All patients (Arm-1 an Arm-2) are followed-up at 6 months after revascularization of common iliac artery obstruction. All participants are reexamined clinically with the use of validated questionnaires, non-interventional uroflow and ultrasound. Molecular biomarkers of ischemia in free-flow urine are performed, as well. Additionally, arm 1 undergoes urodynamic evaluation (UDS)-interventional- at 6 months follow-up.
Intervention code [1] 315196 0
Diagnosis / Prognosis
Comparator / control treatment
All participants in control group are examined clinically with the use of validated questionnaires, non-interventional uroflow and ultrasound. Blood tests and examination for molecular biomarkers of ischemia in free-flow urine are performed.
Control group
Active

Outcomes
Primary outcome [1] 320949 0
Assessment of Lower urinary tract symptoms with the use of IPSS (International Prostate Symptoms Score) in patients before and after revascularization compared to healthy group.
Timepoint [1] 320949 0
Baseline and after completion of 6-months follow up
Secondary outcome [1] 373463 0
Comparison of sexual function changes with the use either of IIEF (International Index of Ererctile Function) questionnaire for men or of FSFI (Female Sexual Function Index) questionnaire for women, in patients with pelvic ischemia before and after revascularization compared to control group.
Timepoint [1] 373463 0
Baseline and after completion of 6-months follow-up
Secondary outcome [2] 373464 0
Changes in uroflow parameters of bladder function in patients before and after revascularization. This is a composite outcome since uroflow parameters include Voided volume, Qmax (maximum urine flow) and PVR (Post-void residual) urine. This is a non-invasive examination where the patient urinates in an machine (uroflow meter) and the volume of urine (in ml) per time (in sec) is recorded. Following that the residual urine in the urinary bladder are measured with the use of ultra sound.
Timepoint [2] 373464 0
Baseline and after completion of 6-months follow-up
Secondary outcome [3] 373466 0
Changes in urodynamics parameters before and after revascularization. This is a composite outcome, since urodynamic parameters include: 1. MCC (maximum cystomanometric capacity), 2. Pdet (detrusor pressure), 3. PVR (post void residual urine) in UDS, 4. presence of overactivity , 5 altered sensation, 6 presence of incontinence.
All the aforementioned parameters are extracted during a urodynamic evaluation (UDS). UDS is an invasive procedure were the bladder is filled with saline via a small catheter and the bladder pressure is recorded during filling and voiding. The volume of urine per time is also recorded. The post void residual is measure after completion of the study, and the evacuation of bladder before the removal of the catheter.
Timepoint [3] 373466 0
Baseline and after completion of 6 months follow-up.
Secondary outcome [4] 373468 0
Comparison of urinary biomarkers in all patients before and after revascularization and also between patients and controls. This is an exploratory outcome based on previous studies in animals.
Timepoint [4] 373468 0
Baseline and after completion of 6 months follow-up for arm 1 and arm 2.
Secondary outcome [5] 376938 0
Assessment of Lower urinary tract symptoms with the use of OAB-q (overactive bladder questionnaire) in patients before and after revascularization compared to healthy group.
Timepoint [5] 376938 0
At baseline and at 6 months follow-up

Eligibility
Key inclusion criteria
1. Patients with pelvic obstructive vascular disease with mild to severe lower urinary tract symptoms (Luts) that are scheduled to be submitted to revascularization.
2. The control group will consist of people without peripheral vascular diseases and do not report Luts (IPSS score < 2 in each question) .
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients that cannot be submitted to revascularization.
2. Patients with a history of operation in lower urinary tract for LUTS or incontinence.
3. Patients with a history of bladder or prostate cancer.
4. Patients with current urinary tract infection.
5. Patients with history of major pelvic operation.
6. Patients with bladder stones.
7. Patients taking medication that affect urination for < 6 months.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Case control
Timing
Both
Statistical methods / analysis
Statistical analysis will include estimation of Cronbach's a for the questionnaires and examination of normality of the results. Following that bivariate analysis using the appropriate parametric and non-parametric test will take place. In detail paired t-test or Wilcoxon signed rank test will be performed in order to compare the results before and after revascularization. Spearman or Pearson test will be used in order to examine the correlation of clinical data with urinary biomarkers. Multivariate analysis will also be performed with IPSS score as an independent variable. Subgroup analysis will be performed when possible for further evaluation of the results
According to a previous similar study, a statistically significant change in IPSS score was noted after 6 months follow-up. In detail IPSS score reduction >4 was recorded in patients that underwent revascularization for iliac artery obstruction. Mean value for IPSS and IPSS-QoL was 13.7±8.4 and 3.3±1.0 initially while in 6 months it dropped at 8.1±6.9 (p<0.001) and 2.1±1.1 (p<0.001) respectively. In a study examining gender stratified normative values of IPSS, participants between 60-64 years old scored 7.16±6.73 while those between 65-69 years old scored 7.3±7.15. In order to achieve comparable results in our study, sample size was estimated at 60 participants (30 patients --arm 1 and 2- and 30 healthy individuals-control group). Doing so will allow comparisons before and after intervention in patients (both arm 1 and 2 ) and also controlling the results with normal population. The estimated power of the study will surpass 80%. Additionally, approximately 20% of the participants will possibly drop-out during the study. In order to overcome this advert event without lose in power of the study the total number of participants rises to 72 (N=36 in each group).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
3/12/2018
Date of last participant enrolment
Anticipated
24/04/2020
Actual
Date of last data collection
Anticipated
24/12/2020
Actual
Sample size
Target
72
Accrual to date
53
Final
Recruitment outside Australia
Country [1] 21760 0
Greece
State/province [1] 21760 0
Thessaloniki

Funding & Sponsors
Funding source category [1] 303406 0
Commercial sector/Industry
Name [1] 303406 0
Astellas Pharma AEBE
Country [1] 303406 0
Greece
Primary sponsor type
University
Name
Aristotle University of Thessaloniki
Address
Aristotle University of Thessaloniki
University Campus
Postal Code 54124. Thessaloniki
Country
Greece
Secondary sponsor category [1] 303632 0
None
Name [1] 303632 0
Address [1] 303632 0
Country [1] 303632 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303935 0
Committee of Bioethics and Ethics of The Faculty of Health Sciences (FHS) of Aristotle University of Thessaloniki (AUTH)
Ethics committee address [1] 303935 0
Ethics committee country [1] 303935 0
Greece
Date submitted for ethics approval [1] 303935 0
Approval date [1] 303935 0
21/11/2018
Ethics approval number [1] 303935 0
1/21.11.2018

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95310 0
Dr Efstathios Papaefstathiou
Address 95310 0
Aristotle University of Thessaloniki, 2nd Urological Department. GH of Thessaloniki Papageorgiou. Ring Road, Postal code 56403. Pavlos Melas, Thessaloniki
Country 95310 0
Greece
Phone 95310 0
+306937721077
Fax 95310 0
Email 95310 0
[email protected]
Contact person for public queries
Name 95311 0
Efstathios Papaefstathiou
Address 95311 0
Aristotle University of Thessaloniki, 2nd Urological Department. GH of Thessaloniki Papageorgiou. Ring Road, Postal code 56403. Pavlos Melas, Thessaloniki
Country 95311 0
Greece
Phone 95311 0
+306937721077
Fax 95311 0
Email 95311 0
[email protected]
Contact person for scientific queries
Name 95312 0
Efstathios Papaefstathiou
Address 95312 0
Aristotle University of Thessaloniki, 2nd Urological Department. GH of Thessaloniki Papageorgiou. Ring Road, Postal code 56403. Pavlos Melas, Thessaloniki
Country 95312 0
Greece
Phone 95312 0
+306937721077
Fax 95312 0
Email 95312 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
No end date, available following publication
Available to whom?
Anyone who wishes to access it
Available for what types of analyses?
any purpose
How or where can data be obtained?
access subject to approvals by Principal Investigator - [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4089Ethical approval  [email protected]
4090Informed consent form  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIRole of Pelvic Ischemia in Human Lower Urinary Tract Symptoms and Sexual Function Among Patients With Common Iliac Artery Obstruction Undergoing Revascularization Surgery2023https://doi.org/10.5213/inj.2346028.014
N.B. These documents automatically identified may not have been verified by the study sponsor.